An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants

Anxiety Clinical Trial

Official title: An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants

Status Completed

Clinical Trial Summary

This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective study, where all subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the a comprehensive set of rating scales in order to best categorize patient responses in regards to anxiety, co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug. This study may be pivotal to the initiation of future double-blind, placebo-controlled studies for this agent

Clinical Trial Description

Acamprosate is felt to restore the normal glutamate-GABA balance in the human brain. (Glutamate is a stimulating chemical in the brain, while GABA is an inhibitory chemical in the brain.) This GABA-glutamate balance is felt to play a role in the development of anxiety. Low GABA and high glutamate levels (similar to the state of alcohol withdrawal) are implicated. Symptoms of anxiety may include worry, sweating, nausea, palpitation, tremor, again comparable to that of alcohol withdrawal. Sometimes, GABA-promoting sedative drugs, such as diazepam (Valium) are used to raise GABA activity to ward of anxiety symptoms in the non-alcoholic patient. GABA sedatives are also used to treat alcohol withdrawal to restore balance over the short term. Given the similar glutamate-GABA imbalance in anxiety states and (post)-alcohol withdrawal states, Acamprosate may be a likely candidate to treat anxiety. Acamprosate is now FDA approved to prolong sobriety and decrease alcohol consumption.

The usual initial treatment for anxiety is to use a serotonin neurotransmitter enhancing drug, such as fluoxetine (Prozac). These 'SSRI' drugs, unlike the sedatives noted above, do not have addiction potential and are safer to use. In addition serotonin-norepinephrine facilitating drugs are also used (SNRIs) as alternatives. In the anxiety disorder population, only 30-70% of patient achieve full relief of anxiety symptoms when placed on SSRI monotherapy. The usual second-line choice to promote full anxiety symptom remission is to add a GABA-sedative to the serotonergic SSRI. The authors feel that Acamprosate, given its ability to manipulate the GABA-glutamate balance without major side effects, nor addiction, may be a reasonable add-on or augmentation strategy to better alleviate anxiety in SSRI partial responders.

This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective study, where all subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the a comprehensive set of rating scales in order to best categorize patient responses in regards to anxiety, co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug. This study may be pivotal to the initiation of future double-blind, placebo-controlled studies for this agent ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

• NCT number: NCT00591565
• Study type: Interventional
• Source: State University of New York - Upstate Medical University
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Completion date: December 2009